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Culturelle
Culturelle is a Biologic drug developed by Fargo VA Medical Center. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Culturelle |
|---|---|
| Sponsor | Fargo VA Medical Center |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Probiotic (LGG) for Veterans With PTSD (PHASE2)
- The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee (NA)
- Probiotics for Autism Spectrum Disorders: a Randomized Controlled Trial (The PASD Study) (NA)
- A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis (NA)
- Single Vs Multi-strain Probiotics for Preterm Neonates (PHASE4)
- Efficacy of Notrande Shuhuajun Probiotic Supplement on Lmproving Constipation in Preschool Children (NA)
- Epigenetic Effects in Children With Cow's Milk Allergy Treated With Different Formulas (NA)
- Nutritional Status in Children With Food Allergy: Evaluation of a New Supplement (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Culturelle CI brief — competitive landscape report
- Culturelle updates RSS · CI watch RSS
- Fargo VA Medical Center portfolio CI
Frequently asked questions about Culturelle
What is Culturelle?
Who makes Culturelle?
What development phase is Culturelle in?
Related
- Manufacturer: Fargo VA Medical Center — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing